External Quality Indicators

External Quality Indicators

High level of satisfaction led to request for expanded services at additional sites

Best In Class Partners

A major strategy to maintain HemaCare’s quality of cells has been to partner with companies which have high quality standards of their own.

Cold (4oC) shipment in HypoThermosol® (BioLife Solutions) has been shown to increase stability of a variety of cell types, and could extend shelf-life of apheresis PBMCs and other cell types.

Cell processing procedures are performed with isolation technology from Miltenyi Biotec. Large scale isolations are done on the Prodigy® and CliniMACS® for an output of billions of cells. Smaller focused isolations are done on the AutoMACS® and manual columns. Both systems were optimized to achieve over 90% purities and over 90% viabilities.

Cryopreservation was implemented with the use of the CoolCell® manual freezing container (BioCision). The containers contain no liquid component and ensure a consistent cooling rate of 1°C/min each use. This in combination with CryoStor™ cryopreservation medium (BioLife Solutions) allows for highly efficient procedures during cryopreservation.

Non-Cryopreserved PBMC StoragePlot Data

Post Thaw QC Data

Upon thawing cryopreserved cells, HemaCare’s recovery has been consistently stable with respect to purity and viability.

Functional Assay

Neutrophils

Summary

Collecting blood-based cellular products in a manner that minimizes variability brings a higher degree of reproducibility to the research project or manufacturing effort